Monthly Archives: July 2016

The Office of the National Coordinator for Health IT advisory group, IXTF, outlined suggestions spanning government policy, technology, and public-private collaborations to improve health data sharing.

The Interoperability Experience Task Force recommended four tactics for enhancing the practice of health information exchange to national coordinator Karen DeSalvo, MD.

Created to advise the Office of the National Coordinator for Health IT, the IXTF suggested actions span policy, technical, and public-private approaches to improve the interoperability experience for providers and patients.

Here are IXTF’s recommendations:

1. Enable providers to effectively use health data. IXTF recommended that ONC stand up two new joint task forces, one to concentrate on reconciling and reducing the burden of importing clinical data, and the other to address IT systems design, usability and testing. ONC should also sponsor develop challenges to fuel user-centered design elements and create a national repository to test data that developers and technology vendors can tap to evaluate user interfaces in a standardized way.

2. Make it cost-effective for providers to exchange health data. IXTF recommended that ONC study total cost of ownership for EHRs as well the cost of patient-mediated exchange, outline best practices for including patient-generated health data in clinical decision-making, and work with the Center for Medicare and Medicaid Innovation to test Open APIs to determine whether to incent their use and what role they plan in IT systems other than EHRs.

3. Advance semantic and syntactic interoperability. This begins with enabling hospital and tech vendors to encode data and, as such, a new task force should home in on making non-clinical and unstructured information more valuable; IXTF cited behavioral data and social determinants of health as prime examples.

4. Monitor existing public-private collaborations. IXTF recommended that ONC engage efforts of Health Level 7 to optimize the CCDA (Consolidated-Clinical Document Architecture) standard, renew work to improve other codesets and terminologies, such as LOINC, collaborate with federal partners such as the National Quality Forum and Veterans Affairs on usability standards and quality measures.

IXTF explained in its letter to DeSalvo that these recommendations come from its own research and testimony by experts and industry professionals during a hearing in May 2016.

Clarification: ONC originally posted the IXTF letter to DeSalvo on its website for a short time then removed it because the Task Force decided more work is needed to focus the recommendations. A spokesperson said the task force chairs delayed the recommendations and took the materials down. So the recommendations could change. We’ll report those as well if changes happen.

HCA Holdings Inc. and Community Health Systems Inc. control a large chunk of the nation’s hospital beds. That gives them significant power to change the health care industry.

So when the two Middle Tennessee hospital giants — and rivals — come together on something, the industry takes notice.

That’s why a new nonprofit group formed to solve health care’s tech woes has courted Milton Johnson and Wayne Smith to join its effort. The CEOs signed on, along with a host of other Nashville and national health care power players, putting serious influence behind the Center of Medical Interoperability that’s building its offices here in Nashville.

Interoperability essentially means the ability of different tech systems to communicate and share data. Technology is rapidly changing health care. And the push for electronic medical records has led to an onslaught of new tech vendors, each with their own proprietary software.

The problem is those systems don’t work together, meaning hospitals and doctors can’t seamlessly share information — which kind of defeats the purpose of going digital in the first place.

The government likely will play a role in solving this dilemma, but health care providers may be in a better position to drive change. They can demand more from their tech vendors by using their checkbooks. When two of the nation’s largest hospital companies say they won’t buy your software if it doesn’t work a certain way, it certainly limits your market share.

That’s the goal of the interoperability center. The center’s director moved the group here to stack its board with the biggest names in health care. And it has, from HCA and CHS to Vanderbilt and Ascension, the parent company of Saint Thomas Health.

Nashville is in a perfect position to lead on this effort. In fact, we have to. The region’s largest industry depends on it, if we want all eyes to stay on Nashville when it comes to health care.

Nashville had long led the way in the world of health care services, largely because we’re home to the two largest for-profit hospital companies in the nation, along with hundreds of other industry players. But larger tech cities are challenging us in the world of health care technology. This center could give us an edge in charting the industry’s future in the world of tech, while holding on to our mantle as the nation’s health care leader.

In today’s cover story, reporter Eleanor Kennedy talked with the man behind the interoperability center and why he chose Nashville to launch this initiative. It’s all about influence and purchasing power.

Two hundred thousand people die every year because of a failure to communicate.

A trillion dollars is wasted every year.

That’s how health care experts set the stage when they talk about one of the biggest concerns facing the industry today: a lack of interoperability.

Yes, it’s a big word. And it’s one that means something different to nearly everyone you ask. But interoperability — the ability for medical records and technologies to seamlessly share data in a way that improves patient care — is a problem Nashville’s health care leaders must get serious about solving.

So the most powerful names in Nashville health care are joining forces to do just that. A nonprofit center ramping up in Nashville has brought together a group of competitors — including Middle Tennessee giants HCA Holdings Inc., Community Health Systems Inc. and LifePoint Health — in an effort to set standards for health care technology.

With the help of government dollars and innovative enthusiasm, entrepreneurs and established companies have spent the past decade developing countless technologies meant to improve care. But without the buy-in of hospital companies, the industry’s been left with hundreds of innovators casting about in the dark, each cultivating their own proprietary corner of the market.

That’s where the Center for Medical Interoperability steps in. Launched with $10 million from two philanthropists in San Diego, the group has front-loaded its board of directors with a slate of names that have the power to bring significant change to health care — and keep Middle Tennessee’s leading industry in the driver’s seat.

Building a powerhouse

Launched by the foundation for Gary and Mary West, two successful technology entrepreneurs, the Center for Medical Interoperability is aimed at creating a centralized lab where the health care industry can solve problems.

The center announced its board members last year. Among them: HCA’s Milton Johnson, CHS’ Wayne Smith and LifePoint’s Bill Carpenter, the CEOs of three of the nation’s five largest publicly traded hospital companies. They sit alongside other national figures (including the heads of Johns Hopkins Medicine and the Robert Wood Johnson Health System)and well-known Nashville leaders like Vanderbilt University Medical Center CEO Dr. Jeff Balser and Dr. Mike Schatzlein, market leader of Indiana and Tennessee ministries for the nation’s largest Catholic hospital system, Ascension, represented locally by Saint Thomas Health.

That who’s who of health care is key to making technology communicate better, said Ed Cantwell, the center’s executive director.

“The reason I came to Nashville is we wanted the largest for-profit and the largest nonprofit to be the anchor,” said Cantwell, who moved the center here from San Diego. “I came here to recruit Ascension and HCA. Little did I know that I would get CHS and LifePoint … and Vanderbilt. So right now those five are really a phenomenal force because they not only represent the diversity of health care, between the five there [is more than] $100 billion a year in revenue.”

That translates to purchasing power that can force vendors to meet standards set by the center’s board, Cantwell argues. The makers of health care technology products could have incentive to prevent their tools from playing well with others, as it might force a customer who’s on their system to buy only their products. But if the nation’s largest hospital companies won’t buy products or systems that don’t work with a broad array of other tools, that incentive goes away.

At a recent Nashville Health Care Council event, Schatzlein said this shift “needs to be driven by the providers.”

If the industry can “come together and certify against standards,” he continued, “we are in a position to implement … and enforce [those standards].”

The center is set to open its new Nashville facility and lab in the OneCity development by the end of this year. Along with the center’s board members, any type of health care business can join the center, which is supported by member dues. The center will not only work to set standards that health-tech products must meet, but it also will house a testing laboratory — designed to employ up to 120 engineers — where those products can be tested and certified for how well they meet the criteria.

“I don’t think anybody that was developing an [electronic medical record] decided to not make their system interoperable. That’s typically not how engineers think,” said Jeff Cunningham, chief technology officer for Nashville-based health tech firm Informatics Corporation of America. “But they were designed for a specific purpose.”

Why the tech doesn’t talk

There are reasons these technologies don’t work together now. First, it’s hard to do.

In the documentary “No Matter Where” — directed by Kevin Johnson, chairman of biomedical informatics at Vanderbilt University Medical Center — a West Tennessee doctor who’d seen care transformed by the effective exchange of information gave up a few years later because the hospital switched software vendors to one he didn’t like.

“I’ve tried to use it, my colleagues have tried to use it, and it’s just not user-friendly,” David Wilcox, a doctor with Memphis’ St. Francis Hospital featured in the film, said of the hospital’s software for sharing information.

But the issues aren’t just about user-friendliness and design. The business incentives also aren’t always there.

For tech vendors and health care providers, there are advantages to keeping your customer — be it the hospital or a patient — tied to your system. Just as a vendor may want to keep a hospital tied to its products, a hospital system may want to keep patients attached to its internal systems so they don’t jump to another provider.

“True interoperability is not good for providers,” Zane Burke, president of health IT giant (and dominant electronic medical record provider) Cerner, said at the recent health care council panel on the issue. “There’s business model challenges in there.”

But, proponents argue, there also are advantages to data sharing, which extend beyond the patient safety rationale so often cited. Dr. Lynn Simon, chief medical officer at Community Health Systems, said increasing interoperability would save CHS money and increase its efficiency in rolling out new technologies.

“Certainly with a lot of time and effort and resources and dollars, anything can be connected together,” Simon said.

But making those systems work together without spending all those resources and dollars would be better for both hospitals and the vendors trying to sell to them, Simon argued.

“If we can’t easily integrate them into our environment, it limits their ability to sell their product, to test their product, to expand their product,” she said.

Without effective communication, providers are “in a bit of stalemate,” said Dr. Jonathan Perlin, chief medical officer and president of clinical services at HCA, because they don’t want to “bet on the wrong horse” and pick a technology that won’t work with their other products or in the industry’s future.

“It’s fundamentally a missed business opportunity,” Perlin continued, comparing the lack of tech communication in health care to the ease of it in other industries — such as the fact that your Sprint cell phone can call your friend’s phone, even if they have AT&T.

“Fundamentally this is a care-quality [and] a safety issue,” Perlin said. “It’s also got the business case on its side, as it’s a financial opportunity for providers, payers, patients and technology vendors in terms of a more efficient health care ecosystem and certainly one that’s far more informed.”

Government’s role:Health care’s efforts still need power of government behind new tech rules

All sorts of other industries come up when health care leaders talk about technologies working effectively together. You can take money out of any bank’s ATM, regardless of where you bank. Your iPhone can send a text message to my Android. Trains from any company can roll down the same tracks.

Those precedents have some in the health care industry convinced that when it comes to making health care technology work together, standards must be set — and enforced — by the government.

“It’s pretty clear that private industry has limited incentives to do the kind of work that gets a national standard up and running quickly,” said Kevin Johnson, chairman of biomedical informatics at Vanderbilt University Medical Center. “That being said,” Johnson continued, Nashville’s new “Center for Medical Interoperability contains the right people … and they’re in the right city at the right time.”

Dr. Jonathan Perlin, chief medical officer at HCA Holdings Inc., has been involved in public-sector efforts to effectively share information and data, serving on the U.S. Department of Health and Human Services Health IT Standards Committee, among similar efforts. He contends solutions will be required from both government and industry leaders.

“We’ve not gotten there entirely by private-sector [efforts], despite shared interest,” Perlin said. But with “increasing frustration and recognition of opportunity,” private-sector operations like the Nashville interoperability center may find success, he continued. “It’s quite an amazing group.”

What’s interoperability?That’s a big word. Here’s what it means to Nashville group

Ed Cantwell’s background isn’t in health care. But the mechancial engineer’s resume — which includes flying jets in the Air Force, working for Texas Instruments and running a wireless company that served health care companies — was enough to lead him to the director’s seat of the Center for Medical Interoperability, a group aiming to make health care technology communicate better.

Cantwell has five criteria he uses to define true interoperability:

1. Plug-and-play (no cost to switching platforms)

2. Two-way (able to both send and receive)

3. One-to-many (the addition of a new device doesn’t throw off what’s already hooked up)

4. Standard space (not proprietary)

5. Truly trusted (guaranteeing safety, privacy and security)

“What happens between [electronic medical record vendors] is data-sharing. … It’s as if I allowed my GPS location of my Ford to go into a database to be accessible to others,” Cantwell said. “True interoperability is the 13 censors in my truck connected to the brakes, connected to a computer, that senses a collision and applies the brakes, even though I might miss it.”

The use of electronic health records for clinical research offers great opportunities to facilitate medical research but there’s a long road ahead before digital records can reliably used for that purpose.

That’s the warning of the American Medical Informatics Association (AMIA), which yesterday filed comments responding to the Food and Drug Administration’s proposed guidance on using EHRs for research purposes.

Both hospitals and physicians are gathering large amounts of information through the electronic records systems they’ve installed in recent years, AMIA noted. But the professional association, which represents the nation’s leading biomedical and clinical informaticians, said it doubted whether those systems contain data of high enough quality that could support randomized controlled trials.

“With more than 96 percent of U.S. hospitals and 83 percent of U.S. office-based physicians using EHRs to deliver clinical care, we have an unprecedented opportunity to utilize digitized healthcare data for supplemental uses, such as clinical investigations,” AMIA said in comments. “However, we strongly caution the FDA from assuming EHRs are readily configurable for clinical investigations, even among more advanced institutions.”

In proposed guidance issued in May, the FDA covers using EHRs that interoperate with electronic systems supporting trials, and discusses ensuring the quality and integrity of data collected and used. The new draft does not include provisions under which the FDA would assess compliance of records systems.

What the FDA eventually decides in this area is important because facilitating the correlation between EHRs and clinical trials would provide significant benefits in speeding and cutting the costs of clinical trials, as well as streamlining the process of finding patients for research.

FDA previously issued guidance on electronic source data in clinical investigations, which acknowledged that data can come from various sources and be entered into the trial sponsor’s Case Report Form (CRF), which is a paper or electronic questionnaire. This could include data from EHRs—this latest proposed guidance focuses on such data.

Another best practice for using EHR data in clinical trials is ensuring the data is attributable, legible, contemporaneous, original and accurate. Further, FDA recommends use of ONC-certified EHRs and other health information technology because of clear differences in interoperability and keeping data confidential.

Non-certified EHRs may be used, but should be assessed to determine if adequate controls are in place to ensure data confidentiality, integrity and reliability. The assessment should include limited access to electronic systems; identification of authors of records; audit trails to track changes to data; and availability and retention of records needed for FDA inspection.

Citing a lack of technical standards and an overreliance on the assurances resulting from ONC’s Health IT Certification Program, AMIA said data generated through the routine course of clinical care would likely fall short of more rigid research standards for data quality and integrity. EHR data is meant to support the care of individual patients, rather than generate research quality data, the organization noted.

“Ensuring data integrity and tracking data provenance in clinical settings is incredibly complicated because multiple, authorized individuals contribute to the EHR and the specificity of audit logs varies widely,” the association said in comments. “If the FDA is interested in which data populated the electronic data capture (EDC) system or electronic case reporting form (eCRF) and where they originated along the continuum of care, the answer could prove extremely difficult and burdensome.”

AMIA recommended FDA update the guidance by pointing clinical investigation sponsors towards data warehouses that utilize a common data model. “These sources may have better semantic interoperability and data integrity compared to sources that remain in the EHR default data model,” the group said.

“If we want to reach the goal of a learning health system, connecting our care systems to our research systems is essential, but we must do it right,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACMI. “Ultimately, we want every patient encounter recorded in the EHR to add to our knowledge about how to do a better job with all patients.”

Health IT Now reacted to the FDA’s proposed guidance, saying more direction is needed for data standards, saying the lack of standards could jeopardize the quality of data used in clinical research.

HITN, a diverse coalition of healthcare providers, patient advocates, consumers, employers and payers who support the adoption and use of health IT to improve health outcomes and lower costs.

“Data collected electronically in the clinical setting or by patients themselves through wearable technology can be useful in clinical research, pre-regulatory approval, and post-approval observation,” HITN’s statement said. “However, one barrier that remains for product sponsors and investigators in leveraging these data is a lack of clarity, especially around acceptable data standards and formats, from the Food and Drug Administration (FDA) and other regulators. Valuable electronic data can be sourced from data registries, wearables, and other forms of health IT which this guidance does not include.”

‘Sometimes when clinicians prescribe medication, although it does therapeutic good, it creates side effects which need to be addressed by changing a dose or by adding additional medications.’

Just as I clarified last week in my post about certification, the answer to the question “do we need more or less healthcare IT regulation and legislation” is that we need the right amount of the right regulation/legislation.

Sometimes when clinicians prescribe medication, although it does therapeutic good, it creates side effects which need to be addressed by changing a dose or by adding additional medications.

Such is the case with HITECH. It was generally good medicine, but now that we’ve seen the side effects on workflow, clinician burden and efficiency, there needs to be a dose adjustment.

I was recently asked to review the “Improving Health Information Technology Act” introduced by Senator Lamar Alexander, R-Tennessee, in February 2016 and placed on the Senate Legislative Calendar in April 2016. Its intent is good – to refine existing healthcare IT legislation with fixes that enable the right amount of the right regulation.

“1) Assisting Doctors and Hospitals in Improving Quality of Care for Patients

Reduces documentation burdens by convening public and private stakeholders to develop goals, a strategy, and recommendations to minimize the documentation burden on providers while maintaining quality.”

This is a good thing. It fixes the language in HITECH which required each stage of Meaningful Use to be more stringent than the last. That language required regulators to make each update to Meaningful Use more challenging.The Improving Health Information Technology Act enables regulators to better balance benefit and burden.

“Allows and encourages health professionals to practice at the top of their license, allowing non-physician members of the care team to document on behalf of physicians.”

This is a good thing. It encourages more team based care and documentation. Using electronic systems effectively is a team sport and should leverage social networking/groupware ideas to capture electronic data.

“Encourages the certification of health information technology for specialty providers and sites of service, like pediatric care, where more specialized technology is needed.”

As long as the Certification focuses on a few key important ideas, as noted in my previous post, this is a good thing.One set of required functionality does not make sense for diverse software supporting specific specialties.

Establishes an unbiased rating system for HIT products to help providers better choose HIT products.”

A government program to do this is unnecessary.The private sector has KLAS and other companies providing such information already.

“Allows HIT users to share feedback on the user experience of specific HIT products related to security, usability, and interoperability, among other concerns.”

A government program to do this is unnecessary. The private sector has KLAS and other companies providing such aggregations already

“3) Information Blocking
a. Gives the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information”

Although I have not personally experienced information blocking, I hear anecdotally that there are some places in the US where competing systems refuse to share data with each other. Giving the OIG the ability to investigate is reasonable.It’s not clear there will be much to investigate.

“4) Interoperability

Convenes existing data sharing networks to develop a voluntary model framework and common agreement for the secure exchange of health information across existing networks to help foster bridging between networks.”

Convening stakeholders to develop a voluntary framework is reasonable. However, I believe the private sector will do this on its own in 2016.

“Creates a digital provider directory to both facilitate exchange and allow users to verify the correct recipient.”

This is a good thing. CMS could leverage the existing national provider identifier system.

“Requires that HHS give deference to standards developed in the private sector.”

This is a good thing. The private sector is moving very fast to embrace simpler standards such as FHIR.

“5) Leveraging Health Information Technology to Improve Patient Care

Requires that certified HIT exchange data with registries if registries are certified to use standards endorsed by the Office of the National Coordinator (ONC).”

There are no mature/adopted standards for registry exchange at this time. In the interest of comprehensiveness, ONC has tended to publish/endorse standards that are not yet ready for adoption. Registry participation should be left to the marketplace.

“Includes vendors in Patient Safety Organizations to allow for improvements in the safety and effectiveness of HIT.”

This is very reasonable

“6) Empowering Patients and Improving Patient Access to Their Electronic Health Information
a. Supports the certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software that may update automatically.”

Although patient and family engagement is very important, it is not something that the government should certify.Apple and other consumer companies are innovating at the speed of the market, taking us in new directions that government could not have predicted.

“Encourages the use of Health Information Exchanges to promote patient access by educating providers and clarifying misunderstandings.”

Health information exchanges really do not have a role in patient/family engagement.The new approaches implemented by Apple and other innovators directly connect the patient and provider.

“Requires HHS to clarify situations where it is permissible for providers to share patient information by providing best practices and common cases where sharing is allowed.”

This is a good thing. We are not going to be able to consolidate records across the care continuum unless we can identify the patient.

There you have it – a dose adjustment for HITECH. Dose adjustments can have their own side effects. Hopefully the bill will be adjusted as suggested above before it is passed. The goal of any new legislation/regulation, just as with medical care itself, should be to first do no harm.

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About the Center

The Center for Medical Interoperability is a 501(c)(3) cooperative research and development lab founded by health systems to simplify and advance data sharing among medical technologies and systems. We provide a centralized, vendor-neutral approach to performing technical work that enables person-centered care, testing and certifying devices and systems, and promoting the adoption of scalable solutions.

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